Diabetic Neuropathy, PainfulNCT05920434
The Effect of Foot Reflexology and Foot Bath on Paın And Qualıty of Lıfe Applıed to Dıabetıc Neuropathıc Paın
A study of Diabetic Neuropathy, Painful, run by Adiyaman Provincial Health Directorate at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Pain relief in diabetic neuropathy is one of the main goals of treatment. Foot reflexology and foot bath, which are two of the important applications of holistic approaches, reduce pain and can significantly increase the quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2020to 22 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants diagnosed with diabetes and the value of HgbA1c ≥ 6.5,
- Participants with the DN4 ≥ 4,
- Participants with the VAS ≥ 4.
Who cannot join
- Participants who were pregnant
- Participants who received any other complementary therapy during the period of the study,
- Participants who had history of systolic blood pressure lower than 100 mmHg in the past,
- Participants who were taking systemic corticosteroids in the previous month,
- Participants who with peripheral artery disease, gonarthrosis, spinal disc herniation, ankle tendonitis, active foot ulcer, and infection
- Participants who had histories of Kidney, heart and brain diseases, rheumatic diseases, thyroid diseases, other hormonal disorders, and malignancy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gaziantep University's Clinical Research Ethics Committee
Introduction: Pain relief in diabetic neuropathy is one of the main goals of treatment. Foot reflexology and foot bath, which are two of the important applications of holistic approaches, reduce pain and can significantly increase the quality of life.
Objective: In the current study, it was aimed to examine the effects of foot reflexology and foot bath applied to diabetic individuals with neuropathic pain on pain and quality of life.
Method: In this randomized controlled study, the sample was randomized into three groups: (I) Foot reflexology (n: 30), (II) Foot bath (n: 30), and (III) Control (n: 30). The "Patient Information Form", "DN4 Pain Questionnaire", "Neuropathic Pain Impact on Quality-of-Life questionnaire (NePIQoL)", and "Visual Analog Scale (VAS)" were used to collect research data. In the study, a protective sensory examination was also performed with the Semmes-Weinstein Monofilament (SWM) Test and the Vibration Test (128 Hz diapason). Apart from these, foot care training was given to all patients included in the practice groups as the role of the diabetes nurse, based on the diabetic foot care training prepared by the Turkish Diabetes Association.
Read the detailed description
(I) Foot reflexology group Individuals in the foot reflexology group were treated by the researcher once a week for a total of 60 minutes, 30 minutes on each foot, for 6 weeks.
(II) Foot bath group In the first meeting, each patient in the foot bath group was informed about the way of doing a footbath in practice. Each patient in the foot bath group was asked to apply a foot bath for 10 minutes, 3 times a week, and twice a day for 6 weeks. A plastic foot bath tub (42 x 37 x 12 cm) without a massage function is provided for each of the patients (Figure 2D). In order not to miss the applications, the patient was followed up by phone on the specified days (3 times a week, Monday-Wednesday-Friday). The patient was told that the foot bath water should be at 40 degrees celsius and that his feet should be kept in water for 10 minutes, approximately 10 cm above the ankle 25. The patient came to the clinic for the forms and protective sensory examination in the 2nd, 4th, and last week.
Control group Forms and protective sensory examination tests were applied to the patients in the control group, as in the intervention groups, and no application was made other than standard nursing care.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- randomized controlled study
- Keywords
- Diabetes, Neuropathic Pain, Foot Reflexology, Foot Bath
- Medical subject headings
- Diabetic Neuropathies, Diabetes Mellitus, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
randomized controlled studyOther
randomized controlled study,no drugs or devices were administered to the participants.
| Study group | Role | What they receive |
|---|---|---|
| Foot reflexology group | Experimental | Individuals in the foot reflexology group were treated by the researcher once a week for a total of 60 minutes, 30 minutes on each foot, for 6 weeks (28,29) (Figure 2C). Receives: Other: randomized controlled study |
| Foot bath group | Experimental | In the first meeting, each participant in the foot bath group was informed about the way of doing a footbath in practice. Each participant in the foot bath group was asked to apply a foot bath for 10 minutes, 3 times a week, and twice a day for 6 weeks. A plastic foot bath tub (42 x 37 x 12 cm) without a massage function is provided for each of the participant s (Figure 2D). In order not to miss the applications, the participant was followed up by phone on the specified days (3 times a week, Monday-Wednesday-Friday). Th participant was told that the foot bath water should be at 40 degrees celsius and that his feet should be kept in water for 10 minutes, approximately 10 cm above the ankle (24). The participant came to the clinic for the forms and protective sensory examination in the 2nd, 4th, and last week. Receives: Other: randomized controlled study |
| Control group | No intervention | Forms and protective sensory examination tests were applied to the participant s in the control group, as in the intervention groups, and no application was made other than standard nursing care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Douleur Neuropathique 4 Questions -It consists of 10 questions in total. The total scale score is calculated by giving 1 point for the yes answer given by the patient to each of the questions and examination findings, and 0 points for the no answer. The lowest score is 0, the highest 10 points can be obtained. is evaluated.
Measured: 6 weeks
Pain severity
Visual Analog Scale (VAS)-It is an equidistant scale on a 10 cm horizontal plane, on one side of which there is no pain and on the other side the pain is "unbearable". The patient is asked to mark the point on this line that best expresses the severity of his or her pain. This distance, measured in millimeters, is interpreted as a "score" .For pain severity, 0 points are "no pain" and 10 points are "worst unbearable pain". evaluated as.
Measured: 6 weeks
Secondary outcomes (2)
Sensory level
Semmes-Weinstein Monofilament (SWM) Test-During the test, the monofilament designed to apply 10 grams of pressure to the patients is touched to the designated areas of the foot until it forms the letter C. Pressure is applied to three different areas (1st metatarsal head, plantar surface of distal hallux, 5th metatarsal plantar surface) on both feet for one second, sufficient to bend the monofilament, and patients are asked whether they feel this pressure. Expression of pressure by the patient in at least two of the three areas on the plantar surface of the foot indicates sensory loss.
Measured: 6 weeks
Vibration sense
Vibration Test (128 Hz) diapason-It is applied to the patients in the supine position with 128 Hz Diaposan.The tuning fork is placed perpendicularly and steadily on the dorsal surface of the distal phalanx of the first toe of the foot .The felt vibration time is recorded and if the patient feels the tuning fork vibration after 10 seconds, it is considered as no vibration sense.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start19 Jul 2020
- Primary completion21 Aug 2020
- Study completion22 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adiyaman Provincial Health Directorate
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reva Gündoğan, Adiyaman Provincial Health Directorate
- Investigators
- Reva Gundogan, Expert Nurse, Study chair, Adıyaman Provincial Health Directorate, Adıyaman Provincial Ambulance Chief Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920434
- Sponsor's protocol ID
- Manuscript: NS-D-22-012
- Status last verified
- Jun 2023
- First submitted
- 1 Feb 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be stored by researchers.
Publications
Zakin E, Abrams R, Simpson DM. Diabetic Neuropathy. Semin Neurol. 2019 Oct;39(5):560-569. doi: 10.1055/s-0039-1688978. Epub 2019 Oct 22.
PubMed 31639839
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gaziantep University's Clinical Research Ethics Committee
- ClinicalTrials.gov ID
- NCT05920434
- Acronym / sponsor ID
- Manuscript: NS-D-22-012
- Conditions
- Diabetic Neuropathy, Painful
- Keywords
- Diabetes, Neuropathic Pain, Foot Reflexology, Foot Bath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Adiyaman Provincial Health DirectorateUniversity, hospital or other
- Study start
- 19 Jul 2020 (actual)
- Primary completion
- 21 Aug 2020 (actual)
- Study completion
- 22 Mar 2021 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Pain relief in diabetic neuropathy is one of the main goals of treatment. Foot reflexology and foot bath, which are two of the important applications of holistic approaches, reduce pain and can significantly increase the quality of life.
Objective: In the current study, it was aimed to examine the effects of foot reflexology and foot bath applied to diabetic individuals with neuropathic pain on pain and quality of life.
Method: In this randomized controlled study, the sample was randomized into three groups: (I) Foot reflexology (n: 30), (II) Foot bath (n: 30), and (III) Control (n: 30). The "Patient Information Form", "DN4 Pain Questionnaire", "Neuropathic Pain Impact on Quality-of-Life questionnaire (NePIQoL)", and "Visual Analog Scale (VAS)" were used to collect research data. In the study, a protective sensory examination was also performed with the Semmes-Weinstein Monofilament (SWM) Test and the Vibration Test (128 Hz diapason). Apart from these, foot care training was given to all patients included in the practice groups as the role of the diabetes nurse, based on the diabetic foot care training prepared by the Turkish Diabetes Association.
Detailed description
(I) Foot reflexology group Individuals in the foot reflexology group were treated by the researcher once a week for a total of 60 minutes, 30 minutes on each foot, for 6 weeks.
(II) Foot bath group In the first meeting, each patient in the foot bath group was informed about the way of doing a footbath in practice. Each patient in the foot bath group was asked to apply a foot bath for 10 minutes, 3 times a week, and twice a day for 6 weeks. A plastic foot bath tub (42 x 37 x 12 cm) without a massage function is provided for each of the patients (Figure 2D). In order not to miss the applications, the patient was followed up by phone on the specified days (3 times a week, Monday-Wednesday-Friday). The patient was told that the foot bath water should be at 40 degrees celsius and that his feet should be kept in water for 10 minutes, approximately 10 cm above the ankle 25. The patient came to the clinic for the forms and protective sensory examination in the 2nd, 4th, and last week.
Control group Forms and protective sensory examination tests were applied to the patients in the control group, as in the intervention groups, and no application was made other than standard nursing care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foot reflexology group | Experimental | Other: randomized controlled studyIndividuals in the foot reflexology group were treated by the researcher once a week for a total of 60 minutes, 30 minutes on each foot, for 6 weeks (28,29) (Figure 2C). |
| Foot bath group | Experimental | Other: randomized controlled studyIn the first meeting, each participant in the foot bath group was informed about the way of doing a footbath in practice. Each participant in the foot bath group was asked to apply a foot bath for 10 minutes, 3 times a week, and twice a day for 6 weeks. A plastic foot bath tub (42 x 37 x 12 cm) without a massage function is provided for each of the participant s (Figure 2D). In order not to miss the applications, the participant was followed up by phone on the specified days (3 times a week, Monday-Wednesday-Friday). Th participant was told that the foot bath water should be at 40 degrees celsius and that his feet should be kept in water for 10 minutes, approximately 10 cm above the ankle (24). The participant came to the clinic for the forms and protective sensory examination in the 2nd, 4th, and last week. |
| Control group | No intervention | –Forms and protective sensory examination tests were applied to the participant s in the control group, as in the intervention groups, and no application was made other than standard nursing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants diagnosed with diabetes and the value of HgbA1c ≥ 6.5,
- Participants with the DN4 ≥ 4,
- Participants with the VAS ≥ 4.
Key exclusion criteria (6 listed)
- Participants who were pregnant
- Participants who received any other complementary therapy during the period of the study,
- Participants who had history of systolic blood pressure lower than 100 mmHg in the past,
- Participants who were taking systemic corticosteroids in the previous month,
- Participants who with peripheral artery disease, gonarthrosis, spinal disc herniation, ankle tendonitis, active foot ulcer, and infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| randomized controlled studyrandomized controlled study,no drugs or devices were administered to the participants. | Other | Foot bath group, Foot reflexology group |
Primary outcome
Pain scores
Time frame: 6 weeks
Douleur Neuropathique 4 Questions -It consists of 10 questions in total. The total scale score is calculated by giving 1 point for the yes answer given by the patient to each of the questions and examination findings, and 0 points for the no answer. The lowest score is 0, the highest 10 points can be obtained. is evaluated.
Pain severity
Time frame: 6 weeks
Visual Analog Scale (VAS)-It is an equidistant scale on a 10 cm horizontal plane, on one side of which there is no pain and on the other side the pain is "unbearable". The patient is asked to mark the point on this line that best expresses the severity of his or her pain. This distance, measured in millimeters, is interpreted as a "score" .For pain severity, 0 points are "no pain" and 10 points are "worst unbearable pain". evaluated as.
2 secondary outcomes
Sensory level
Time frame: 6 weeks
Vibration sense
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Background: PubMed 31639839Zakin E, Abrams R, Simpson DM. Diabetic Neuropathy. Semin Neurol. 2019 Oct;39(5):560-569. doi: 10.1055/s-0039-1688978. Epub 2019 Oct 22.
- Google internet linkLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD will be stored by researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reva Gundogan, Expert Nurse study chair
Adıyaman Provincial Health Directorate, Adıyaman Provincial Ambulance Chief Physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetic Neuropathy, Painful, run by Adiyaman Provincial Health Directorate at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.